During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient aged 18 years old or more
* Patient with newly diagnosed previously untreated de novo, secondary or therapy-related AML
* Patients with R/R de novo, secondary or therapy-related AML
* Patient with Health insurance
Exclusion Criteria:
* Acute promyelocytic leukemia
* AML which is not morphologically proven (patients with granulocytic sarcoma may be included)
* For newly diagnosed AML: previous treatment of leukemia apart from hydroxyurea. Previous anti leukemia treatments are allowed if they were administered before the diagnosis of AML to treat a MDS, MPN, MPN/MDS or CML
* Patient weighting less than 50 kgs
* Opposition of the patient to participate to this non-interventional study
More specific eligibility criteria might be requested to enter some study modules
Primary outcome measure(s)
OS — 1 year The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
OS — 3 years The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
OS — 5 years The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
OS — 10 years The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
EFS — 1 year The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
EFS — 3 years The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
EFS — 5 years The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
EFS — 10 years The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
* From first treatment initiation in patients with newly diagnosed AML
* From the date of relapse/refractoriness (R/R) in patients, with R/R AML
Trial sites (30)
Facility
City
Region
Status
Chu Amiens
Amiens
France
Recruiting
Centre Hospitalier Victor Dupouy
Argenteuil
France
Recruiting
AP-HP-GHU - Hôpital AVICENNE
Bobigny
France
Recruiting
CHU de la cote de Nacre
Caen
France
Recruiting
Hôpital MILITAIRE PERCY
Clamart
France
Recruiting
Centre hospitalier Sud Francilien
Corbeil-Essonnes
France
Recruiting
Hôpital Henri Mondor AP-HP
Créteil
France
Recruiting
CHU Dijon- François Mitterrand
Dijon
France
Active Not Recruiting
Centre Hospitalier de Dunkerque
Dunkirk
France
Recruiting
Centre Hospitalier de Versailles André Mignot
Le Chesnay
France
Recruiting
Centre Hospitalier Dr Schaffner
Lens
France
Recruiting
CHRU de Lille- Hopital C. HURIEZ
Lille
France
Recruiting
GHICL-Hopital St Vincent de Paul
Lille
France
Recruiting
C H U DE LIMOGES- Hopital Dupuytren
Limoges
France
Recruiting
CHU La Conception
Marseille
France
Recruiting
Centre Hopsitalier de l'Est Francilien - Site de Meaux
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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